Nanobiotechnology December 2022/January 2023 Viewpoints
2022: The Year in Review
By Ivona Bradley
Toxicity to the body is one of the factors preventing many nanomedicine technologies from reaching patients. Many R&D initiatives in nanomedicine fail to pass the initial stage of development because the nanomedicine technologies harm the body. Nevertheless, the great potential that nanomaterials have to improve treatments for existing conditions and to treat rare diseases will continue to fuel R&D in this area in 2023. Companies will continue to advance the commercialization of CRISPR (clustered regularly interspaced short palindromic repeats) technologies aggressively in 2023. Although commercial products are unlikely to reach the health-care market for some time, investors and developers will move forward with more clinical trials, planning to negotiate technology licenses as intellectual-property rights become clear. Unintended off‑target edits remain a matter of concern. But next-generation sequencing tools will find use to identify whether CRISPR causes unintended mutations. Antimicrobial resistance and once‑common viral and bacterial infections caused by bacteria and viruses that covid‑19-pandemic restrictions prevented many people from building immunity to will continue to pose threats to successful medical care—predominantly in the first quarter of 2023. Vaccine technologies and medical materials (some of which contain nanotechnologies) will be crucial to fighting these infections.
Key Developments Identified by SBI in 2022
- Covid‑19 and Nanobiotechnology Advances. Since scientists first detected and sequenced SARS‑CoV‑2 in 2020, the nanobiotechnology field has seen a surge in R&D, leading to improvements in pathogen detection, disease diagnosis, transmission control and filtration, patient treatment, and safety. Supply-chain reorganization in response to the covid‑19 pandemic and in preparation for future threats will likely prioritize nanobiotechnology.
- Updated Definition of Nanomaterials. Following a lengthy review process that took place between 2013 and 2021, the European Commission has finally published its recommendation on updating the 2011 definition of nanomaterials. Regulations are dependent on firm definitions, and the new recommendation will likely enable lawmakers to develop and update effective nanomaterials and nanotechnology regulations and guidance that are in line with new technological developments. Such effective regulations could accommodate the risks of nanotechnology in novel product developments.
- Cancer-Fighting mRNA Vaccines Enter Clinical Trials. Organizations are extensively researching messenger‑RNA (mRNA) therapies for treating cancer, and already some mRNA vaccines are showing results in small clinical trials. The move into bigger clinical trials proves that the field is advancing rapidly. If successful, the research will significantly alter options for management and treatment of cancer.
- Detecting Aerosol Nanoparticles in the Workplace. Researchers believe that occupational exposure to nanoparticles during manufacturing can have harmful effects on human health. A new exposure device that can be part of health-and-safety equipment in a nanotechnology workplace has the potential to increase both the productivity of producers and the acceptance of nanotechnology across a wide range of industries.
- A Predictive Screen to Streamline Nanoparticle R&D. Because of physiological differences between animal models and humans, promising nanotechnologies do not necessarily translate from the lab to the clinic. A preclinical screen based on mice models could predict the efficacy of lipid nanoparticles as a drug-delivery system in humans. The predictive technique is likely to inform decisions and promote the efficient allocation of resources.
- Imaging Nucleic Acids at the Nanoscale. Limitations on imaging capabilities for technologies smaller than 100 nanometers greatly hinder research and development. Two US teams separately developed single-particle-imaging techniques that will help researchers predict nucleic-acid behavior and fine-tune existing technologies and have applications in nanomedicine, biotech, and nanoelectronics.
- Metamaterial-Based Genetic-Screening Platform. Scientists have developed a genetic-screening platform that makes use of high-quality-factor metasurfaces to offer label-free rapid detection. Potential biosensing applications are many, including applications in biomarker research, diagnostics, and detection of infectious microorganisms. Applications within the medical-diagnostics sector could attract funding for nanoscale-biosensor development.
- United States Upholds Decisive CRISPR‑Cas9 Patent Claim. As developers try to navigate intellectual-property disputes about the use of gene-editing technology CRISPR‑Cas9 (clustered regularly interspaced short palindromic repeats-CRISPR associated protein 9), a 2022 legal ruling in support of the Broad Institute's patent claim for CRISPR‑Cas9 application in crops, animals, and humans offers some clarity for commercialization in the United States. However, CRISPR‑Cas9 represents a relatively small share of the overall CRISPR market.
- CRISPR Blood Test for Tuberculosis Diagnosis. Tuberculosis remains one of the leading causes of mortality on a global scale. A novel CRISPR‑based biosensor can detect tuberculosis with greater efficacy than can standard sputum tests, rapidly generating results in patient populations that are challenging to diagnose. Regulatory and licensing ambiguity could impede commercialization, though risks are low for this medically essential technology.
- Regenerating the Spinal Cord with Dynamic Nanofibers. A new nanotechnology harnesses the power of molecular motion to promote spinal‑cord regeneration in mice. Upon injection, a peptide-based solution forms a dynamic, fibrous network that mimics the extracellular matrix, activating stem cells and facilitating cellular communication. This breakthrough could dramatically improve the recovery of patients with paralysis and debilitating neurological conditions.
- Molecular Machines in Nanomedicine. Molecular machines are molecules that contain both a stationary and a rotating component. Scientists are able to induce rapid rotation using light, turning molecular machines into nanoscale turbines, gears, pumps, sensors, and now drills that act as microbial killing machines. The molecular machines could puncture holes in pathogen membranes and even clear up antibiotic-resistant bacterial infections.
Areas to Monitor Highlighted by SBI in 2022
Macro/Dynamic Issues (Frequently Featured)
The application of nanoscale-material technologies in drug delivery provides better bioavailability, biocompatibility, efficacy, and selectivity than are available with conventional therapy modalities. Effective delivery of drugs is a key goal for pharmaceutical companies as they build their novel-drugs pipeline.
Diagnostic-platform developments target more individualized capabilities through multiplexing of biological levels of information. Such developments of nanoscale diagnostic applications could benefit from the use of quantum dots, gold nanoparticles, and other nanomaterials with high sensitivity and selectivity.
The ability to direct biological organisms—which range from ribosomes to viruses and bacteria—to operate as templates for the orderly fabrication of more complex materials and structures could lead to opportunities to manufacture electronic, optical, and magnetic materials with uniform and clearly defined structures.
Advances in gene-editing techniques such as CRISPR-Cas will expand fundamental knowledge and enable the development of applications for nucleic acids. Scientists around the world are very active in the development of CRISPR-based therapies for a variety of application areas, including medicine and agriculture.
Micro/Semi-Stable Issues (Sometimes Featured)
A company's IP strategy is subservient to its commercialization strategy and business model. For example, a company that intends to commercialize a technology itself may choose to do a limited amount of patenting and retain most of the IP in the form of trade secrets. Patents may protect, but they also give away a lot of information.
Technology commercialization cannot proceed without investment, and well-capitalized technologies almost always advance faster than do technologies with limited funding. Investment trends to monitor include those relating to venture capital, corporate R&D budgets, defense projects, and government investment.
Nanobiotechnology can play a significant role in the design of new biomaterials. Nanotechnology facilitates not only use of nanoparticles as carriers for therapeutics but also development of biocompatible materials in medical applications that include nanomaterial coatings for medical devices and nanoscale sensors in diagnostics devices.
Nucleic-Acids Research Developments
Globally, scientists are very active in the development of nucleic-acid-based materials for a variety of applications. Advances in gene-editing techniques such as CRISPR‑Cas will enable scientists to overcome the lack of fundamental knowledge that is a major barrier to the development of nucleic-acid applications.
The selectivity of living cells—including animal and bacteria cells—offers great value and utility in drug screening and analysis of complex biological fluids. Advances in biosensor development will accelerate the use of living cells in screens for drug discovery, environmental monitoring, and diagnostics.
Tissue engineering promises to change the way physicians treat many diseases and injuries. Scientists around the world are very active in the development of nanomaterials for use in tissue replacement; however, few studies in this area have left the laboratory and entered the clinical-trial stage.
Look for These Developments in 2023
- Increasing number of mRNA clinical trials. The research of mRNA vaccines has accelerated rapidly because of the covid‑19 pandemic. Expect to see an increase in the number of research organizations that plan to start clinical trials to test the clinical viability of mRNA technologies for the treatment of various diseases, including cancer.
- Increasing use of nanodiagnostics. Look for nanotechnology-enabled diagnostics devices that can demonstrate exceptional value. The wide use of such devices may cause disruptions to the use of the conventional tests that physicians currently rely on to diagnose cancer and various other diseases.
- Increasing accessibility of DNA/RNA sequencing. Technological advances, smaller benchtop and handheld devices, and increasing competition in the market for sequencing continue to drive down the cost of sequencing, increasing the speed of whole-human-genome sequencing and making sequencing practical for an expanding variety of applications. Because sequencing is becoming more accessible, science's understanding of genetics will accelerate, which will have wide-ranging implications for nanotechnology.
- Continuing synthetic-biology research. Advances in genetic engineering and protein engineering will aid the creation of synthetic biological systems. Cutting-edge research in synthetic biology continues to focus on creating wholly synthetic versions of fundamental biological units. With this kind of synthetic biology, the capabilities of biological materials will no longer restrict bioproducts, which could gain entirely new qualities and functions.